Dental Pulp CappingNCT03403985
Long-term Evaluation of Direct Pulp Capping
A study testing Calcium Hydroxide (Ca(OH)2) and Mineral Trioxide Aggregate in people with Dental Pulp Capping and Dental Caries Extending to Pulp, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
Calcium hydroxide and mineral trioxide aggregate have been used in vital pulp therapy with variable outcomes recorded by different study. They will be compared when used for direct pulp capping in cariously exposed mature permanent teeth. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Capping, Dental Caries Extending to Pulp
- What is being tested?
- Calcium Hydroxide (Ca(OH)2) and Mineral Trioxide Aggregate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jun 2017to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- carious teeth that had no previous root canal treatment
- Pulpal diagnosis of normal or reversible pulpitis
Who cannot join
- History of irreversible pulpal pain
- Immature teeth
- Non restorable teeth
- Teeth with active periodontal disease
- History of any systemic disease
- Concurrent medication with systemic steroids, antibiotics, analgesics, immunomodulatory drugs or cytotoxics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Evaluation of Direct Pulp Capping Using Either Mineral Trioxid Aggregate or Calcium Hydroxide in Permanent Mature Teeth: A Randomized Controlled Trial
Calcium hydroxide and mineral trioxide aggregate have been used in vital pulp therapy with variable outcomes recorded by different study. They will be compared when used for direct pulp capping in cariously exposed mature permanent teeth.
Read the detailed description
Vital pulp therapy has the benefit of providing patients with a conservative treatment option with relatively low cost when compared to conventional root canal treatment and spares them possible post-treatment consequences that might occur. Vital pulp treatment in trauma cases is associated with high success rate but controversy still exists regarding vital pulp treatment in carious-exposed pulp.
The purpose of this study is to evaluate the success rate of direct pulp capping performed with MTA-Angelus® or calcium hydroxide in mechanical-exposed or carious-exposed mature permanent human teeth. Patients included in this study will be recruited from routine dental patients attending conservative clinics in JUST Dental Teaching Centre. Adult patients scheduled for routine conservative treatment involving caries removal and restoration with mechanical or carious pulp exposure will be invited to participate in this study.
A total of 80 carious human teeth with carious pulp exposure will be included in this randomized clinical study. Patients are among those scheduled for conservative dental treatment and end with pulp exposure. The patients and/or their parents will be asked to sign a consent form after receiving a detailed explanation about the study rationale, clinical procedures, and possible risks. The exposed teeth will be divided randomly into two experimental groups (n=40) according to the dressing materials; MTA-Angelus® or calcium hydroxide, then teeth will be restored with permanent filling. Teeth will be reviewed recording any signs and symptoms. Patients will be reviewed in 1 week, 3 months and yearly after. MTA-Angelus and calcium hydroxide are anticipated to be biocompatible and induce hard tissue barrier. This project will reveal if tested materials are presented with promising profile upon using as direct pulp capping dressing in mechanical and carious-exposed pulp.
- Being tested
- Calcium Hydroxide (Ca(OH)2), Mineral Trioxide Aggregate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide (Ca(OH)2)Drug
Also called Ca(OH)2
Ca(OH)2 will be used in this group
Mineral Trioxide AggregateDrug
Also called MTA
MTA will be used in this group
| Study group | Role | What they receive |
|---|---|---|
| calcium hydroxide direct pulp capping | Experimental | calcium hydroxide (Ca(OH)2 direct pulp capping will be performed in this group Receives: Drug: Calcium Hydroxide (Ca(OH)2) |
| MTA direct pulp capping | Experimental | Mineral Trioxide Aggregate (MTA) direct pulp capping will be performed in this group Receives: Drug: Mineral Trioxide Aggregate |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical vital pulp therapy success
Treatment was considered successful based on the absence of symptoms and signs Treatment was considered successful based on absence of symptoms and signs
Measured: from date of randomization until failure reported for up to 100 months
Secondary outcomes (1)
Radiographic success
treatment could be further evaluated based on the absence of canal oblitration
Measured: from date of randomization until failure reported for up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Jun 2017
- Primary completion28 Jun 2017
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp CappingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Retrospective clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lama Awawdeh, PhD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403985
- Sponsor's protocol ID
- JordanUST2
- Status last verified
- Sep 2019
- First submitted
- 5 Jan 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation of Direct Pulp Capping Using Either Mineral Trioxid Aggregate or Calcium Hydroxide in Permanent Mature Teeth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03403985
- Acronym / sponsor ID
- JordanUST2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Calcium hydroxide and mineral trioxide aggregate have been used in vital pulp therapy with variable outcomes recorded by different study. They will be compared when used for direct pulp capping in cariously exposed mature permanent teeth.
Detailed description
Vital pulp therapy has the benefit of providing patients with a conservative treatment option with relatively low cost when compared to conventional root canal treatment and spares them possible post-treatment consequences that might occur. Vital pulp treatment in trauma cases is associated with high success rate but controversy still exists regarding vital pulp treatment in carious-exposed pulp.
The purpose of this study is to evaluate the success rate of direct pulp capping performed with MTA-Angelus® or calcium hydroxide in mechanical-exposed or carious-exposed mature permanent human teeth. Patients included in this study will be recruited from routine dental patients attending conservative clinics in JUST Dental Teaching Centre. Adult patients scheduled for routine conservative treatment involving caries removal and restoration with mechanical or carious pulp exposure will be invited to participate in this study.
A total of 80 carious human teeth with carious pulp exposure will be included in this randomized clinical study. Patients are among those scheduled for conservative dental treatment and end with pulp exposure. The patients and/or their parents will be asked to sign a consent form after receiving a detailed explanation about the study rationale, clinical procedures, and possible risks. The exposed teeth will be divided randomly into two experimental groups (n=40) according to the dressing materials; MTA-Angelus® or calcium hydroxide, then teeth will be restored with permanent filling. Teeth will be reviewed recording any signs and symptoms. Patients will be reviewed in 1 week, 3 months and yearly after. MTA-Angelus and calcium hydroxide are anticipated to be biocompatible and induce hard tissue barrier. This project will reveal if tested materials are presented with promising profile upon using as direct pulp capping dressing in mechanical and carious-exposed pulp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Retrospective clinical trial
| Arm | Type | Receives |
|---|---|---|
| calcium hydroxide direct pulp capping | Experimental | Drug: Calcium Hydroxide (Ca(OH)2)calcium hydroxide (Ca(OH)2 direct pulp capping will be performed in this group |
| MTA direct pulp capping | Experimental | Drug: Mineral Trioxide AggregateMineral Trioxide Aggregate (MTA) direct pulp capping will be performed in this group |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- carious teeth that had no previous root canal treatment
- Pulpal diagnosis of normal or reversible pulpitis
Key exclusion criteria (6 listed)
- History of irreversible pulpal pain
- Immature teeth
- Non restorable teeth
- Teeth with active periodontal disease
- History of any systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium Hydroxide (Ca(OH)2)Also: Ca(OH)2Ca(OH)2 will be used in this group | Drug | calcium hydroxide direct pulp capping |
| Mineral Trioxide AggregateAlso: MTAMTA will be used in this group | Drug | MTA direct pulp capping |
Primary outcome
clinical vital pulp therapy success
Time frame: from date of randomization until failure reported for up to 100 months
Treatment was considered successful based on the absence of symptoms and signs Treatment was considered successful based on absence of symptoms and signs
1 secondary outcome
Radiographic success
Time frame: from date of randomization until failure reported for up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lama Awawdeh, PhD principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Hydroxide (Ca(OH)2) and Mineral Trioxide Aggregate in people with Dental Pulp Capping and Dental Caries Extending to Pulp, run by Jordan University of Science and Technology at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical vital pulp therapy success (time frame: from date of randomization until failure reported for up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.